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A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

4 giugno 2026 aggiornato da: Jecho Biopharmaceuticals Co., Ltd.

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

Panoramica dello studio

Stato

Completato

Condizioni

Infezioni da HIV

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Cina
- - Beijing, Cina
    - Peking Union Medical College Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests (hematology, urinalysis, serum chemistry, infectious disease screening, coagulation) are normal or have no clinically significant abnormality.
Male or female, age 18 to 55 years inclusive.
Body weight: male ≥50.0 kg, female ≥45.0 kg. Body mass index (BMI) between 18.0 and 26.0 kg/m² inclusive. BMI = weight (kg) / height (m)².
No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
No plans for pregnancy within 6 months, and agreement to use effective contraception with their partner from screening until 3 months after the study completion. No donation of sperm or eggs during this period.

Exclusion Criteria:

Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
Lactating women; women of childbearing potential with menstrual disorders within 90 days before dosing; women of childbearing potential who had unprotected intercourse with a male partner within 28 days before dosing.
Participation in any clinical trial of an investigational drug within 90 days before dosing, or still within the safety washout period of a previous trial on the day of dosing.
Non-physiological blood loss of ≥200 mL (including trauma, blood draw, blood donation) within 60 days before dosing, or plan to donate blood during the study or within 30 days after dosing.
Any major illness considered clinically significant by the investigator within 90 days before dosing.
Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
Fever or infectious illness within 28 days before dosing.
Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
History or dependence of alcohol or drug abuse, or drug use, or a positive urine drug screen at screening. Alcohol abuse defined as average weekly intake >21 standard alcohol units. One standard unit contains 14 g of alcohol (e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine).
Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
Vital signs at screening meeting any of the following: systolic blood pressure <90 mmHg or >140 mmHg; diastolic blood pressure <50 mmHg or >90 mmHg; pulse rate <50 beats/min or >100 beats/min.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
Any other condition that, in the investigator's judgment, might affect the study results or interfere with the subject's participation throughout the study, including but not limited to other medical history (e.g., psychiatric disorder), abnormalities in vital signs, physical examination, electrocardiogram, or clinical laboratory tests.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione sequenziale
Mascheramento: Triplicare

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Arm 1: JL18008 1 μg/kg Single intramuscular injection of JL18008 at 1 μg/kg.	Droga: JL18008 1 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.
Comparatore placebo: Arm 2: Placebo (for 1 μg/kg group) Single intramuscular injection of placebo (JL18008 buffer).	Droga: Placebo (for 1 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 1 μg/kg.
Sperimentale: Arm 3: JL18008 5 μg/kg Single intramuscular injection of JL18008 at 5 μg/kg.	Droga: JL18008 5 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 5 μg/kg.
Comparatore placebo: Arm 4: Placebo (for 5 μg/kg group) Single intramuscular injection of placebo.	Droga: Placebo (for 5 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 5 μg/kg.
Sperimentale: Arm 5: JL18008 10 μg/kg Single intramuscular injection of JL18008 at 10 μg/kg.	Droga: JL18008 10 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 10 μg/kg.
Comparatore placebo: Arm 6: Placebo (for 10 μg/kg group) Single intramuscular injection of placebo.	Droga: Placebo (for 10 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 10 μg/kg.
Sperimentale: Arm 7: JL18008 20 μg/kg Single intramuscular injection of JL18008 at 20 μg/kg.	Droga: JL18008 20 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 20 μg/kg.
Comparatore placebo: Arm 8: Placebo (for 20 μg/kg group) Single intramuscular injection of placebo.	Droga: Placebo (for 20 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 20 μg/kg.
Sperimentale: Arm 9: JL18008 40 μg/kg Single intramuscular injection of JL18008 at 40 μg/kg.	Droga: JL18008 40 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 40 μg/kg.
Comparatore placebo: Arm 10: Placebo (for 40 μg/kg group) Single intramuscular injection of placebo.	Droga: Placebo (for 40 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 40 μg/kg.
Sperimentale: Arm 11: JL18008 70 μg/kg Single intramuscular injection of JL18008 at 70 μg/kg.	Droga: JL18008 70 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 70 μg/kg.
Comparatore placebo: Arm 12: Placebo (for 70 μg/kg group) Single intramuscular injection of placebo.	Droga: Placebo (for 70 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 70 μg/kg.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0 Lasso di tempo: Up to 56 days	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). AEs graded according to NCI CTCAE version 5.0. Assessed from Day 1 through Day 56.	Up to 56 days

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change from Baseline in White Blood Cell Count (WBC) Lasso di tempo: Up to 56 days	Change from baseline in white blood cell count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Neutrophil Count (NEUT) Lasso di tempo: Up to 56 days	Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Eosinophil Count (EOS) Lasso di tempo: Up to 56 days	Change from baseline in eosinophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Basophil Count (BASO) Lasso di tempo: Up to 56 days	Change from baseline in basophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Lymphocyte Count (LYMPH) Lasso di tempo: Up to 56 days	Change from baseline in lymphocyte count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Red Blood Cell Count (RBC) Lasso di tempo: Up to 56 days	Change from baseline in red blood cell count. Measured in 10¹²/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hemoglobin (HGB) Lasso di tempo: Up to 56 days	Change from baseline in hemoglobin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Platelet Count (PLT) Lasso di tempo: Up to 56 days	Change from baseline in platelet count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hematocrit (HCT) Lasso di tempo: Up to 56 days	Change from baseline in hematocrit. Measured as a percentage (%). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Bilirubin (TBIL) Lasso di tempo: Up to 56 days	Change from baseline in total bilirubin. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Protein (TP) Lasso di tempo: Up to 56 days	Change from baseline in total protein. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Albumin (ALB) Lasso di tempo: Up to 56 days	Change from baseline in albumin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT) Lasso di tempo: Up to 56 days	Change from Baseline in Alanine Aminotransferase (ALT)	Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST) Lasso di tempo: Up to 56 days	Change from baseline in aspartate aminotransferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Gamma-Glutamyl Transferase (γ-GT) Lasso di tempo: Up to 56 days	Change from baseline in gamma-glutamyl transferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Creatinine (Cr) Lasso di tempo: Up to 56 days	Change from baseline in creatinine. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Cholesterol (TCHO) Lasso di tempo: Up to 56 days	Change from baseline in total cholesterol. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Triglycerides (TG) Lasso di tempo: Up to 56 days	Change from baseline in triglycerides. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Urea Nitrogen (BUN)/Urea Lasso di tempo: Up to 56 days	Change from baseline in blood urea nitrogen. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alkaline Phosphatase (ALP) Lasso di tempo: Up to 56 days	Change from baseline in alkaline phosphatase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Glucose (GLU) Lasso di tempo: Up to 56 days	Change from baseline in blood glucose. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Phosphorus (Pi) Lasso di tempo: Up to 56 days	Change from baseline in serum phosphorus. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Sodium (Na⁺) Lasso di tempo: Up to 56 days	Change from baseline in serum sodium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Potassium (K⁺) Lasso di tempo: Up to 56 days	Change from baseline in serum potassium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Calcium (Ca²⁺) Lasso di tempo: Up to 56 days	Change from baseline in serum calcium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Magnesium (Mg²⁺) Lasso di tempo: Up to 56 days	Change from baseline in serum magnesium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Chloride (Cl-) Lasso di tempo: Up to 56 days	Change from baseline in serum chloride. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in International Normalized Ratio (INR) Lasso di tempo: Up to 56 days	Change from baseline in international normalized ratio. Unitless ratio. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT) Lasso di tempo: Up to 56 days	Change from Baseline in Activated Partial Thromboplastin Time (APTT)	Up to 56 days
Change from Baseline in Prothrombin Time (PT) Lasso di tempo: Up to 56 days	Change from baseline in prothrombin time. Measured in seconds. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Fibrinogen (FIB) Lasso di tempo: Up to 56 days	Change from baseline in fibrinogen. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in ECG Parameter: QTcF Interval Lasso di tempo: Up to 56 days	Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Systolic Blood Pressure (SBP) Lasso di tempo: Up to 56 days	Change from baseline in systolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Diastolic Blood Pressure (DBP) Lasso di tempo: Up to 56 days	Change from baseline in diastolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Pulse Rate Lasso di tempo: Up to 56 days	Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Peak Plasma Concentration (Cmax) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Maximum observed plasma concentration following single intramuscular injection. Measured in pg/mL. Assessed at pre-dose and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Time to reach maximum observed plasma concentration. Measured in hours (h). Same time points as Cmax.	Up to 672 hours after first dose
Elimination Half-Life (t½) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Elimination half-life calculated as ln(2)/λz. Measured in hours (h).	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose Lasso di tempo: Up to 672 hours after first dose	AUC using linear trapezoidal rule. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Extrapolated AUC. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC₀-₁₆₈ₕ) - Single Dose Lasso di tempo: Up to 168 hours after first dose	AUC from 0 to 168 hours post-dose. Measured in h·pg/mL.	Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Dose divided by AUC₀-∞. Measured in L/h.	Up to 672 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose Lasso di tempo: Up to 672 hours after first dose	Dose divided by (λz × AUC₀-∞). Measured in L.	Up to 672 hours after first dose
Change from Baseline in CD4⁺ T Cell Count Lasso di tempo: Up to 56 days	Change from baseline in absolute CD4⁺ T cell count. Measured in cells/μL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1320 hours post-dose.	Up to 56 days
Change from Baseline in CD8⁺ T Cell Count Lasso di tempo: Up to 56 days	Change from baseline in absolute CD8⁺ T cell count. Measured in cells/μL. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in CD4/CD8 T Cell Ratio Lasso di tempo: Up to 56 days	Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Unitless ratio. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in Serum Interleukin-2 (IL-2) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IL-2 level. Measured in pg/mL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-4 (IL-4) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IL-4 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-6 (IL-6) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IL-6 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-8 (IL-8) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IL-8 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-10 (IL-10) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IL-10 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum TNF-α level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interferon-gamma (IFN-γ) Level Lasso di tempo: Up to 672 hours (28 days)	Change from baseline in serum IFN-γ level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Number of Participants with Anti-Drug Antibodies (ADA) Lasso di tempo: Up to 56 days	Incidence of anti-drug antibodies (ADA) against JL18008. For ADA-positive participants, titers and neutralizing antibodies (Nab) will be assessed. Assessed at baseline and at 168, 336, 504, 672, 1320 hours post-dose.	Up to 56 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jecho Biopharmaceuticals Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 giugno 2024

Completamento primario (Effettivo)

5 agosto 2025

Completamento dello studio (Effettivo)

5 agosto 2025

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

JL18008-HV/HIV INR-101（Ia）
CTR20241578 (Identificatore di registro: Drug Clinical Trial Registration and Information Disclosure Platform, Center for Drug Evaluation, NMPA, China)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Cina
Baylor College of Medicine
George Washington University; Children's National Research Institute

Completato

Sicurezza e immunogenicità di un vaccino candidato contro l'anchilostoma umano con diverse dosi di un nuovo adiuvante

Infezione da anchilostomi | Malattia da anchilostomi

Stati Uniti
ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

Completato

RAB001（LLP2A-Ale） in Soggetti Sani (LLP2A-Ale)

Osteonecrosi della testa del femore

Cina
General Hospital of Ningxia Medical University

Completato

Infusione profilattica di norepinefrina combinata con coloading colloidale per l'ipotensione dell'anestesia postspinale

Evento avverso

Cina
Cairo University

Reclutamento

Dexmedetomidina intratecale con bupivacaina, in pazienti sottoposti a chirurgia ortopedica del ginocchio

Bupivacaina | Dexmedetomidina intratecale | Chirurgia Ortopedica del Ginocchio

Egitto
EVIVE Biotechnology
Sun Yat-sen University; Fudan University

Completato

Uno studio di farmacocinetica/dinamica Ib sull'F-627 in donne con cancro al seno sottoposte a chemioterapia mielotossica

Neutropenia

Cina

A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Prove cliniche su Infezioni da HIV

Prove cliniche su JL18008 1 μg/kg

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Croatia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi